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Mifepristone pretreatment followed by misoprostol 200 mcg buccal for the medical management of intrauterine fetal death at 14-28 weeks: A randomized, placebo-controlled, double blind trial.
Bracken, Hillary; Ngoc, Nguyen Thi Nhu; Ha, Do Quan; Paredes, Norberto Reyes; Quyet, Vu Ba; Linh, Nguyen Thi Huyen; Ortiz, Marco Antonio; Bousieguez, Manuel; Winikoff, Beverly.
Affiliation
  • Bracken H; Gynuity Health Projects, 220 East 42(nd) Street, Suite #710, New York, NY 10017, United States. Electronic address: hbracken@gynuity.org.
  • Ngoc NTN; Center for Research and Consultancy in Reproductive Health (CRCRH), 16 D Luy Ban Bich, Tan Thoi Hoa - Tan Phu, Hochiminh City, Viet Nam.
  • Ha DQ; Dept. of Scientific Research and Technology Development, National Obstetrics and Gynecology Hospital, 43, Trang Thi, Hoan Kiem District, Hanoi, Viet Nam.
  • Paredes NR; National Institute of Perinatology (INPer), Montes Urales # 800, Lomas - Virreyes, Lomas de Chapultepec IV Secc, 11000 Mexico City, Mexico. Electronic address: norberto.reyes@inper.gob.mx.
  • Quyet VB; National Obstetrics and Gynecology Hospital, 43, Trang Thi. Hoan Kiem District, Hanoi, Viet Nam.
  • Linh NTH; National Obstetrics and Gynecology Hospital, 43, Trang Thi. Hoan Kiem District, Hanoi, Viet Nam.
  • Ortiz MA; National Institute of Perinatology (INPer), Montes Urales # 800, Lomas - Virreyes, Lomas de Chapultepec IV Secc, 11000 Mexico City, Mexico. Electronic address: marco.ortiz@inper.gob.mx.
  • Bousieguez M; Gynuity Health Projects, 220 East 42(nd) Street, Suite #710, New York, NY 10017, United States. Electronic address: mbousieguez@gynuity.org.
  • Winikoff B; Gynuity Health Projects, 220 East 42(nd) Street, Suite #710, New York, NY 10017, United States.
Contraception ; 102(1): 7-12, 2020 07.
Article in En | MEDLINE | ID: mdl-32135126
OBJECTIVE: To evaluate whether fetal and placental expulsion is more likely within 48 h if women receive mifepristone pre-treatment vs placebo pre-treatment followed by misoprostol 200 mcg buccally for treatment of fetal death at 14 weeks 0 days to 28 weeks and 6 days gestation. STUDY DESIGN: We randomized 176 women with a confirmed fetal death between 14 weeks and 0 days to 28 weeks and 6 days to mifepristone 200 mg or placebo; 24 h later all participants received misoprostol 200 mcg buccally every 3 h for up to 16 doses or 48 h. The trial took place in Hanoi, Vietnam and Mexico City in 2015-2018. RESULTS: Complete expulsion of the fetus and placenta within 48 h of misoprostol administration occurred in 74 of 90 women (82.2%, 95% confidence interval (CI), 72.7%-89.5%) in the mifepristone-misoprostol group and in 70 of 86 women (81.4%, 95% CI, 71.6%-89.0%) in the placebo-misoprostol group (Relative Risk (RR) 1.01, 95%CI 0.87-1.16, p = 0.887). The median time from the start of the misoprostol induction to fetal expulsion was shorter among women who received mifepristone-misoprostol compared to women assigned to placebo-misoprostol (7 h vs ±5 vs 12 ± 13 h; p < 0.001). Women in the mifepristone-misoprostol group were more likely to expel the fetus within 24 h of the start of misoprostol administration (96% vs 78%; RR 1.22 (1.09-1.39) p = 0.009). CONCLUSION(S): Mifepristone-misoprostol did not result in a higher rate of complete expulsion of the fetus and the placenta within 48 h of the start of misoprostol administration without any additional surgical intervention or medication (e.g. additional misoprostol doses or oxytocin) than placebo-misoprostol. However, treatment with mifepristone-misoprostol did result in a shorter time to expulsion than placebo misoprostol. IMPLICATIONS: Pretreatment with mifepristone followed by misoprostol bucally resulted in a shorter treatment time for medical management of fetal death than treatment with misoprostol alone. Pre-treatment with mifepristone may be more acceptable to women and providers by both reducing the length of hospital stay and the amount of misoprostol required.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Abortifacient Agents, Nonsteroidal / Abortifacient Agents, Steroidal / Misoprostol / Abortion, Induced Type of study: Clinical_trials / Etiology_studies Limits: Female / Humans / Pregnancy Language: En Journal: Contraception Year: 2020 Document type: Article Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Abortifacient Agents, Nonsteroidal / Abortifacient Agents, Steroidal / Misoprostol / Abortion, Induced Type of study: Clinical_trials / Etiology_studies Limits: Female / Humans / Pregnancy Language: En Journal: Contraception Year: 2020 Document type: Article Country of publication: United States